February 4, 2015
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 2/4/2015 Class lI: PRODUCT Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 2/4/2015 Class lI: PRODUCT BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging Recall Number Z-1011-2015 REASON Unintended detector and gantry movement due to software issues. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc.,Cleveland, OH 11/12/2014. Voluntary:...
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Company: INNOKAS MEDICAL OY. Date of Enforcement Report 2/4/2015 Class lI: PRODUCT VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. Recall Number Z-1022-2015 REASON If the SpO2 or RRa value is violating the respective alarm...
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Company:GE Healthcare Date of Enforcement Report 2/4/2015 Class lI: PRODUCT The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. Recall Number...
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